Annex U: USDA Performance Standards for Salmonella

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U.1 Introduction

The "Pathogen Reduction/HACCP Systems" Final Rule requires that certain types of meat products made in Food Safety and Inspection Service (FSIS) inspected establishments meet United States Department of Agriculture (USDA) "Performance Standards" for Salmonella published under sections 9CFR310.25(b) and 9CFR381.94(b) of the US Federal Register. The FSIS performs unannounced sampling and testing of products manufactured in US facilities in order to assess their compliance with the standards. If an establishment cannot produce meat which conforms with the prescribed Performance Standard, a process which can ultimately lead to the withdrawal of inspection is initiated. The FSIS will also use these test results to update baseline reference standards for Salmonella in US products and to update the Performance Standards for Salmonella.

Canadian establishments eligible to export meat or meat products to the US which are amenable to a USDA Performance Standard for Salmonella (see section 11.7.3.2.2.1.2 on the US in Chapter 11) must manufacture these products in accordance to the applicable standard. In order to demonstrate this, the establishment shall conduct testing of products for Salmonella according to a written sampling program which meets the requirements set out in this annex.

The Canadian Food Inspection Agency (CFIA) exercises government direction and oversight of establishments' Salmonella testing programs. If an establishment's testing shows that it is not manufacturing product which complies with the USDA Performance Standard for Salmonella, a process is initiated which may lead to the removal of the establishment from the list of eligible establishments. If the establishment fails to meet the requirements for Salmonella testing set out in this annex, the CFIA will initiate the process set out in section 11.2.3.2 (5) (B) of Chapter 11.

The CFIA intends to eventually use Canadian Performance Standard for Salmonella. Pending their publication and acceptance, the Performance Standards published by the USDA will be used in Canadian establishments.

Differences between USDA Performance Standard for Salmonella and generic E. coli (biotype I) testing requirements

The purpose of USDA Performance Standard for Salmonella is different than that of generic E. coli (biotype I) testing requirements. As a result, the consequences of unsatisfactory test results differ.

USDA Performance Standards for Salmonella were designed to verify that establishments meet USDA's pathogen reduction goals. FSIS selected Salmonella as a performance indicator for four reasons:

  1. Salmonella is the most common bacterial cause of food borne illness;
  2. Salmonella colonizes a variety of species and occurs at a frequency which allows for the monitoring of changes in its incidence;
  3. current methodologies allow for the recovery and identification of Salmonella; and
  4. intervention strategies aimed at the reduction of Salmonella in raw products should be effective against other pathogens.

The requirement for generic E. coli (biotype I) testing is meant to achieve the implementation of microbiological-based Statistical Process Controls (SPC) in establishments preparing specific types of meat products. Generic E. coli (biotype I) is the organism to test because it is easy to test for and is common enough to provide a good indication of process control.

Because generic E. coli (biotype I) testing requirements are designed around Performance Verification Criteria (PVC), which are often establishment specific, the same test result may be lead to a different conclusion in two establishments which have different PVC. Generic E. coli (biotype I) is done on an ongoing basis using a moving window approach. Failure in meeting PVC is a deficiency only when the establishment is unable or unwilling to successfully bring their process back "in control" (refer to section T.2.9 of Annex T, Corrective Actions When the Process is not "In Control" for details on handling this type of situation).

Salmonella testing serves a different purpose. It is done to verify that the establishment is manufacturing product in accordance with the prescribed Performance Standard. It is not a method for SPC. A moving window approach is not used, instead a series of stand alone samples is taken. Unlike E. coli, individual tests are evaluated as "+" or "-" for the presence of Salmonella, no matter the actual number of Salmonella detected. If the number of "+" results during the series exceeds the maximum allowed during three consecutive series of tests, this is considered as a serious deficiency, even if the establishment is making every reasonable effort to correct the problem and is dealt with as a more serious matter than failure to meet E. coli PVC.

U.1.1 Canadian establishments which must implement a Salmonella testing program in order to satisfy US requirements

All Canadian registered establishments listed under section 11.7.3.2.2.1 on the US in Chapter 11 which manufacture a product amenable to USDA Performance Standards for Salmonella must issue product which meets the applicable Performance Standard(s).

With the exception of the following types of establishments, all establishments must implement a testing program.

Establishments which are not required to conduct testing

  1. Establishments which manufacture ground meat (beef, chicken or pork sausage) are exempted only if:
    • the establishment makes the class of product less than 26 times. This determination is based on how often the class of product was made during the previous year as well as on predicted production information for the coming year (i.e., additions to the plant.)

    For example, an establishment which makes ground beef 20 times a year, ground chicken 20 times a year and ground turkey 30 times a year is only required to test the class of product which is made more than 26 times during the year (ground turkey).

  2. Red meat slaughter establishments (steers/heifers; cows/bulls; market hogs) are exempted only if:
    • the establishment slaughters less than 400 carcasses a year; and
    • the establishment slaughters less than 35 weeks a year.

    Base this determination on how often the class of animal was slaughtered during the previous year as well as on predicted production information for the coming year (i.e., additions to the plant.)

U.1.2 Products amenable to USDA Performance Standard for Salmonella

If a USDA Performance Standard for Salmonella has been published for the class of product, all corresponding products made within the establishment must comply with the standard. Table U.1.2 lists all USDA Performance Standards for Salmonella published to date.

USDA Performance Standards were based on microbial baseline studies conducted by the USDA. Further baseline studies will be performed and Performance Standards for new classes of product will be added to this list.

Table U.1.2 - USDA Performance Standards for Salmonella by class of product
Class of Product Status
Steer/heifer carcasses Published
Cow/bull carcasses Published
Ground beefTable Note 1 Published
Hog carcasses Published
Young chicken carcassesTable Note 2 Published
Ground chickenTable Note 1 Published
Young Turkey carcassesTable Note 2 Published
Ground turkeyTable Note 1 Published

Table Notes

Table note 1

Does not apply to meat which is ground as a processing step in the fabrication of a processed meat product (e.g., beef ground to make salami).

Return to table note 1  referrer

Table note 2

Refer to Annex U-1 for further information relevant to Salmonella and Campylobacter testing of chilled carcasses of young chickens and turkeys.

Return to table note 2  referrer

U.1.3 Requirement to manufacture product which complies with the applicable Performance Standard for Salmonella and to conduct annual testing

Establishments which manufacture a meat product amenable to a USDA Performance Standards for Salmonella are required to manufacture the product in conformance with the applicable standard at all times. In order to demonstrate this, the establishment shall conduct regular Salmonella testing at least once per year in accordance with the requirements set out in this annex.

If an establishment manufactures products which correspond to more than one class of USDA Performance Standards for Salmonella, all of the establishment's products must meet the applicable Performance Standard. However, the establishment is not required to perform an annual set of tests on each class of product. A decision regarding which of the classes will be sampled during the year will be made by the CFIA Veterinarian/Inspector in Charge (V/IIC) (see section U.1.6.1 for details).

U.1.4 [Reserved]

U.1.5 Responsibilities under these testing requirements

U.1.5.1 Responsibility of the establishment operator

Establishments must prepare a written sampling program for Salmonella which adheres to the sample collection, preparation and shipping procedures and technical criteria set out in this annex (refer to section U.2 for details). After the program has been reviewed by the CFIA V/IIC using the applicable Compliance Verification System (CVS) task, the establishment is required to conduct their sampling activities in accordance with their written program and must:

  1. manufacture products which comply with the applicable published USDA/FSIS Performance Standard for Salmonella;
  2. present the CFIA with a written annual Salmonella testing program which meets the requirements of this annex;
  3. conduct the Salmonella testing program on the class(es) of product identified by the CFIA V/IIC in conformity with the accepted written program and the requirements of this annex;
  4. arrange for laboratory results to be sent simultaneously and directly to the CFIA V/IIC;
  5. keep records and test results in a manner consistent with the requirements outlined in section U.4;
  6. compile testing results to show the status of compliance with the Performance Standard for Salmonella;
  7. initiate appropriate corrective action if the number of positive Salmonella test results exceeds the maximum number of positives per set (see U.2.2);
  8. make available to CFIA inspection staff on request all information relevant to the establishment's Salmonella sampling program (including written procedures, laboratory reports and analytical results) for purposes of compliance verification; and
  9. assume the cost for sampling, testing and other activities related to the program.

Establishments must only use laboratories which meet the accreditation criteria set out in section U.3 and which employ the methodology referred to in this annex for the detection and identification of Salmonella. Finally, the establishment must make arrangements with the laboratory so that samples of all Salmonella positive cultures are available to the CFIA upon request.

U.1.5.2 Responsibilities of accredited laboratories

  1. Maintaining laboratory accreditation under the Standards Council of Canada (SCC) or the Canadian Association for Laboratory Accreditation Inc. (CALA) under the Standards "General requirements for the competence of testing and calibration laboratories" ISO/IEC 17025:2005 and "Requirements for the Accreditation of Agriculture Inputs, Food, Animal Health and Plant Protection Testing Laboratories (ref. CAN-P-1587 April 2008)
  2. Demonstrate ongoing proficiency for Salmonella testing through the "Microbiology Proficiency Testing Program" jointly administered by the SCC and the CFIA.
  3. Either admitting or disposing of samples for Salmonella testing according to the criteria described in 2.2.1.
  4. Conducting testing for Salmonella according to the technical requirements referred to in this annex.
  5. Sending results for each individual test simultaneously and directly to the CFIA V/IIC for the establishment.
  6. Making available to the CFIA V/IIC information on the condition of samples received.

U.1.5.3 Responsibilities of the CFIA

The CFIA:

  1. requires and verifies that the laboratories used for analysis of samples are accredited by the Standards Council of Canada or the Canadian Association for Laboratory Accreditation Inc. (CALA) under the Standards "General requirements for the competence of testing and calibration laboratories" ISO/IEC 17025:2005 and "Requirements for the Accreditation of Agriculture Inputs, Food, Animal Health and Plant Protection Testing Laboratories (ref. CAN-P-1587 April 2008) for the reporting of Salmonella test results;
  2. on an annual basis, verifies that the establishment's written Salmonella testing programs meets the requirements of this annex and determines the scope of Salmonella testing at the establishment through the use of applicable CVS task and the "determination of class(es) to sample for Salmonella" worksheet;
  3. during each week of Salmonella testing, randomly performs on-site verification of the establishment Salmonella testing activities (e.g., sample taking, preparation and shipment) using applicable CVS task to verify adherence to the written program and to requirements;
  4. obtains copies for each individual test results simultaneously and directly from the laboratory;
  5. directly receives test results, evaluates and compares them to those of the establishment to verify that the establishment is properly compiling results and informing the CFIA whenever the number of Salmonella positive results exceeds the specified limit;
  6. V/IIC compiles data on Salmonella results and sends a report to H.Q. for the production of Canadian national Salmonella baselines and Performance Standards;
  7. reviews the establishment's proposed actions when the limit is exceeded;
  8. V/IIC takes appropriate compliance action (see section 11.2.3.2 (5) (B) of Chapter 11); and
  9. V/IIC requires, as directed by the Operation Veterinarian Specialist-Meat Export or substitute, that the operator conducts a supplementary set of Salmonella tests if process is deemed out of control.

U.1.6 CFIA verification of testing and related CVS tasks

U.1.6.1 Review of the establishment's written program by the CFIA using applicable CVS task

Once a year, prior to the commencement of the upcoming calendar year, the CFIA V/IIC performs applicable CVS task and completes the "determination of class(es) to sample for Salmonella" worksheet (copy provided in section U.6) in order to verify that the establishment's written testing program for Salmonella is satisfactory and to determine which class(es) of product will be sampled for Salmonella through a points value system.

A copy of the completed CVS task and worksheet will be kept by the V/IIC. In cases where the V/IIC finds that a condition is not being met, they are to document the situation and advise the Operation Veterinarian Specialist-Meat Export or substitute. No testing shall begin until all of the items specified in applicable CVS task have been assessed as satisfactory by the V/IIC.

The "determination of class(es) to sample for Salmonella" worksheet is designed to allow for a uniform determination of which class(es) to sample at establishments and takes the following factors into consideration:

  • results of previous Salmonella testing;
  • results of generic E. coli (biotype I) testing;
  • production volumes and types of products made at the establishment;
  • modifications to manufacturing practices;
  • products made at the establishment which have not been tested previously;
  • other relevant information; and
  • any specific testing instructions received from the CFIA Operation Veterinarian Specialist-Meat Export or substitute..

The worksheet in section U.6 is used in the following manner:

  • the establishment makes available to the V/IIC production information for each (Performance Standard for Salmonella) class of product made at the establishment;
  • this information is used by the V/IIC to complete the worksheet;
  • the worksheet will assign a points value to each class of product made at the establishment;
  • testing for Salmonella shall be done on:
    • the class of product with the highest point score (in case of tie, testing for Salmonella will be done on the product which is produced in greatest quantity by weight); as well as
    • all classes of products which have a total point score of 5 or more.
  • the V/IIC and the establishments will set the date when the testing of the class(es) will commence and this date will be recorded on the form.

Testing may begin at any point during the year, however the selection of the starting date needs to be based on valid reasons and these reasons are to be stated in the written program.

U.1.6.2 Verification of the establishment's implemented program by the CFIA using applicable CVS tasks

A special CVS task exists for verifying that the establishment is conducting Salmonella testing in accordance with its written program. The V/IIC will conduct random on-site verification at least once during each week that Salmonella testing takes place at the establishment. In cases where the V/IIC finds that a condition is not being met, they are to document the situation and advise the Operation Veterinarian Specialist-Meat Export or substitute.

U.2 Technical requirements

U.2.1 Written protocol and procedures; written records

The technical requirements outlined in this section were developed using information published by the USDA in the US Federal Register (Vol 61, No. 144/ July 25, 1996, page 38917) under the title "FSIS Sample Collection Guidelines and Procedure for Isolation and Identification of Salmonella from Raw Meat and Poultry Products" and further information which was provided directly to the CFIA by the USDA.

The operator shall have a written program for Salmonella sampling done at the establishment and make it available to the CFIA V/IIC upon request. The written program shall contain procedures covering all the establishment's areas of responsibility. The procedures shall be detailed to the extent necessary to enable on-site verification. The following information must be included in the written program:

  • the list of products manufactured at the establishment which are covered by a Performance Standard for Salmonella (classified by Salmonella sampling class of product);
  • information regarding the sampling plan used and the selection of samples, e.g., how many samples to be taken, who carries out the sampling, when and where sampling will be done, how random sampling of carcasses will be achieved;
  • information regarding pre-sample preparation: i.e., check list of tasks to be performed prior to sample collection, materials needed for sample collection, verification of the suitability of materials before testing (e.g.: sponges checked to ensure they will support growth);
  • the sampling procedure used;
  • the shipping procedures used: e.g., who packages, where is packaging done, where are samples kept pending shipment, who ships samples; where are samples shipped (laboratory) / how are samples shipped (shipping agent);
  • the means to tamper-proof and protect the integrity of samples: e.g., how samples are handled/packaged and shipped to ensure temperature maintenance and tamper proofing;
  • the identity of the laboratory used to provide results and proof of the laboratory's current accreditation for Salmonella testing;
  • the procedure for providing the CFIA V/IIC directly and simultaneously with Salmonella test results;
  • the procedures for compiling test results and record keeping: e.g., who receives test results, who reviews and compiles data, where are lab reports/worksheets kept, how long are records kept;
  • the operator's internal monitoring and/or verification activities to verify that the program is delivered as intended;
  • the corrective action procedures to be taken for items such as: inconclusive test results, non-compliances with the program that the operator identifies during their internal verification activities, for Salmonella positive results; for a cumulative number of Salmonella positive test results which exceed the "fail" threshold for a set of tests; and
  • the CFIA notification procedures: e.g., who in the company will notify the V/IIC when the tests are completed/if the number of positive tests within a set exceeds the "fail" threshold.

Reference may be made to an establishment's general sample collection procedures provided that the references are to the procedure specific sections and that details specific to Salmonella sampling procedures are provided. Procedures may also be written into the establishment's Hazard Analysis Critical Control Point (HACCP) plans.

U.2.2 USDA performance standards for Salmonella by class of product

Number of tests per set ("n" value); Maximum number of positives per set ("c" value)

The USDA Performance Standards for Salmonella were developed by the USDA FSIS based on a statistical analysis of the data collected by USDA through Salmonella baseline studies performed in the US. Because the percentage of Salmonella positive results was different between the different classes of product tested during the baseline study, the USDA developed Performance Standard and sampling plans for each class of product.

Table U.2.2
USDA Performance Standards for Salmonella by class of product
Sources: Code of Federal Regulations, Ch. 9, 310.25 (7), Jan. 1st 2012; and FSIS Notice 54-12 (09/11/ 2012)
Class of Product Number of Samples to be tested per set ("n") Maximum Number of Positives per set ("c")
Steer/heifer carcasses 82 1
Cow/bull carcasses 58 2
Ground beef 53 5
Hog carcasses 55 6
Young chickens 51 5
Ground chicken 53 26
Young turkey carcasses 56 4
Ground turkey 53 29

U.2.2.1 Sampling rates and frequency of sampling

Table U.2.2 indicates the number of samples to be collected and tested in order to complete one set of tests. Sampling plans are designed to ensure similar accuracy of results between product classes with different prevalence levels for Salmonella. The number of tests to be done varies between classes of product because of statistical requirements.

Tests must be taken on consecutive days until the set of tests is completed. Once a set of tests has been started by the operator, samples shall be taken by the operator at the rate of one sample taken at random on each consecutive production day until the number of conclusive laboratory test results (i.e., either negative or positive) for Salmonella is equal to the "n" value published in Table U.2.2 for the class of product.

On the day that the first sample is to be taken, the operator shall advise the CFIA V/IIC that a set of Salmonella tests has begun. The operator must conclude the set of tests once it is started. It is not acceptable to stop testing once a set has begun or to re-start testing.

Procedure for dealing with laboratories which are unable to begin the analysis of certain samples within 24 hours of sample taking because of week-end and holiday closures. If the laboratory used is closed on a given day and this makes it impossible to initiate the analysis of samples within 24 hours of the sample being taken, the following additional procedures shall be used:

For poultry carcasses: the carcasses shall continue to be selected at random during each production day. They shall be held under refrigeration and shall be kept under strict control at the establishment until the earliest time at which the samples could be taken and shipped to the laboratory for analysis within 24 hours of shipment.

For example: if the laboratory is closed on Sunday, but the establishment operates 7 days a week, daily random carcass selection shall still be performed on Saturday and on Sunday. The carcasses shall be kept under refrigeration and under control of the operator at the establishment. The samples are to be taken and shipped by the operator to the laboratory the next business day when the laboratory can conduct the tests within 24 hours of shipment.

For red meat carcasses: A carcass shall still be selected for sampling at random from each day of production, but when the laboratory cannot begin the analysis of the sample within 24 hours, the operator shall:

  • randomly select the carcass after 12 hours or more of chilling; and
  • place the selected carcass in a designated area and delay the sample collection on the carcass until 24 hours before the laboratory can receive and initiate analysis of samples.

For example: The establishment operates on Friday and Saturday (it is closed on Sunday) and the laboratory is closed on Saturday and Sunday. As usual, a carcass is selected at random among the carcasses produced on Friday and another carcass among Saturday's production, and both of the selected carcasses are placed and kept in a designated area. The selected carcasses are sampled at the earliest time at which and the samples can be sent to the laboratory for analysis within 24 hours of shipment.

For ground meat samples: the sample shall continue to be selected at random during each production day. They shall be held under refrigeration and will be prepared for shipment, but shall be kept under strict control at the establishment until the earliest time at which it can be shipped to the laboratory for analysis within 24 hours of shipment.

For example: if the laboratory is closed on Sunday, but the establishment operates 7 days a week, a daily sample shall still be taken at random on Saturday and on Sunday. The samples shall be packaged and stored kept under refrigeration and under control of the operator at the establishment. The samples are to be shipped by the operator to the laboratory the next business day when the laboratory can conduct the tests within 24 hours of shipment.

Inconclusive test results and "make-up" samples: Inconclusive laboratory results will not be counted. For each inconclusive result (e.g., a sample received after 24 hours or in unsatisfactory conditions), a "make-up" sample must be added to the set. These samples will be taken in the same manner as regular samples on the consecutive production day(s) following the initial number of samples.

U.2.2.2 Assessment of an individual set of tests

A set of tests is concluded when the total number of conclusive (i.e. negative or positive) laboratory results is equal to the "n" value specified in table U.2.2 for the class of product. The evaluation of the establishment's performance is based the total number of Salmonella positive results found within the set of results. In order to have successfully completed the set of tests, the establishment must:

  • have a number of valid and conclusive (i.e., negative or positive) laboratory results equal to the number of samples to be sampled within the set ("n" value); and
  • have a total number of Salmonella positive test results which does not exceed the maximum number of Salmonella positive results permitted for a single set of samples ("c" value).

If the number of Salmonella positive test results exceeds the "c" value, the establishment has not successfully completed the set of tests and further actions are to take place.

Note: In the case of samples from young chicken and turkey carcasses, a set of samples must meet both Salmonella and Campylobacter standards (refer to Annex U-1 for performance standards of the latter). If the set of tests fails for one pathogen but passes for the other, the company must collect follow-up sample sets for analysis of both organisms. CFIA's response will follow current Salmonella procedures with respect to immediate follow-up testing for both organisms and in-depth analysis when deemed necessary.

U.2.2.3 Conclusion of tests for the year

The establishment shall notify the CFIA V/IIC when the set of tests is completed. The V/IIC is to review the establishment's data. If the data is satisfactory and the total number of Salmonella positive results for the set of tests is equal or less than the published "c" value for the class of product, no further testing of this class of product is required for this year.

If the establishment has committed in its annual Salmonella testing program to also test other classes of product, testing for each of the other classes must still be completed.

If an establishment has not completed the number of sample required to complete the set by the end of the calendar year (e.g., establishments which produce low volumes of product), they shall continue to collect samples during the following production days until they have the number of results required to complete the set. If the results for this set are negative, the establishment will begin any testing specified for the new calendar year (as provided for under section U.1.6). If the set is positive, the provisions of the following sections U.2.2.4 and U.2.2.5 will apply.

U.2.2.3.1 Considerations when testing samples of young chicken and turkey carcasses

When testing carcasses of young chickens or turkeys, the samples must meet the standards for both Salmonella and Campylobacter. If failing, the operator must collect follow-up samples for retesting of the two microorganisms: second or third sets of samples could clearly extend to the following year. In such cases, the operator will not be required to collect an additional series for that calendar year: CFIA will accept the results of the follow up set to meet the requirement of regular annual sampling for the class of product that is being retested.

U.2.2.4 Actions when the number of positive test results during the first set of tests exceeds the maximum number of positives per set ("c" value)

There are two possible reasons for this occurring during the first set of tests:

  1. the establishment is producing product which has a Salmonella incidence greater than the US national prevalence used for setting the Performance Standard; or
  2. the establishment is producing product which has a Salmonella incidence lower than the US national prevalence used for setting the Performance Standard, but "fails" because of statistical reasons related to how the Performance Standards are designed.

When the number of positive test results exceeds the specified "c" value, the establishment shall investigate the possible causes for the results (e.g.: lack of adherence to the HACCP plan, procedures or CCPs which are not sufficiently effective, etc.) and draw up an action plan to correct the situation. The establishment shall communicate its findings and action plan to the V/IIC in writing within 5 working days after the "c" value has been exceeded.

If the set of tests has not yet been completed, the establishment shall continue to take samples at the normal rate until the required number of test results (number of tests equal to the "n" value) has been obtained. This is important as it will allow for a complete analysis of the situation. If further positives are identified, the establishment shall review its action plan, amend it as required and inform the V/IIC of the changes made.

Within 5 working days of receiving the final results for the set of tests, a report shall be prepared by the establishment and given to the V/IIC. All action plans as well as a summary of testing results shall be attached to the report. The V/IIC is to forward the report to the Operation Veterinarian Specialist-Meat Export or substitute and attach their comments.

The Operation Veterinarian Specialist-Meat Export or substitute reviews this information to decide on when the operator shall begin the second set of tests. Depending on the total number of positive results, the time lines contained within the establishment's action plan and the corrective actions which have been initiated by the operator, the Operation Veterinarian Specialist-Meat Export or substitute may provide the operator with time to complete the implementation of the corrective actions before starting the second set of tests. However, should the establishment's action plan be unsatisfactory or be not adhered to, the Operation Veterinarian Specialist-Meat Export or substitute will instruct that the establishment begin the second set of tests immediately.

The second set of tests shall be performed in the same way as the first and test results assessed in the same manner. If the total number of Salmonella positive test results for the second set of tests does not exceed the maximum number of positives per set ("c" value), the establishment is said to have successfully completed the set of tests and no further testing for the class of product will be required for the year. If not, see U.2.2.5.

U.2.2.5 Actions when the number of positive test results during a second set of tests exceeds the maximum number of positives ("c" value)

If, during the second set of tests, the number of positive test results for Salmonella exceeds the maximum number of positives allowed during the set ("c" value), the establishment shall immediately notify the V/IIC.

This type of situation is believed to indicate a strong likelihood of serious shortcomings in the establishment's HACCP plan(s) for the class of product sampled. The establishment shall immediately conduct a systematic review of all HACCP plans for the products within the class sampled and shall immediately initiate any corrective actions that are indicated as a result of this review.

The establishment shall communicate the results of this investigation along with an action plan to the V/IIC in writing within 5 working days of having notified the V/IIC that the number of Salmonella results exceeding the maximum number per set ("c" value). As per Food Safety Enhancement Program (FSEP) requirements, all changes to the establishment HACCP System must be recorded in the HACCP System modification logbook and must be reviewed by the CFIA FSEP specialist team when conducting the applicable CVS Section  4 tasks.

The V/IIC is to provide the Operation Veterinarian Specialist-Meat Export or substitute a copy of the establishment's report and attach their comments. Inspection activity frequencies for the affected product(s) and process(es) should be reviewed. The Operation Veterinarian Specialist-Meat Export or substitute will also initiate any further appropriate actions.

The establishment shall continue to take samples for Salmonella until it has completed the set of samples (i.e. has a number of conclusive test results equal to the "n" value). Any further Salmonella positive test results shall be immediately communicated to the V/IIC. If further positives are identified, the establishment shall review its action plan, amend it as required and inform the V/IIC of the changes made. The V/IIC will review the results and the establishment operator's written response and report their findings to the Operation Veterinarian Specialist-Meat Export or substitute.

When there have been two consecutive sets of Salmonella tests where the number of Salmonella positive test results for each set of tests has exceeded the maximum number of positives (i.e. greater than "c" value), a third and final set of tests will be required. The date when this third set of tests must begin will be communicated to the establishment by the Operation Veterinarian Specialist-Meat Export or substitute. Provided that the establishment has presented a reasonable time within its action plan for the implementation of changes to its HACCP system and adheres to this action plan, the Operation Veterinarian Specialist-Meat Export or substitute may set the beginning date for the third set of testing after the implementation and validation of the HACCP System changes and the verification and recognition of these changes by the CFIA.

The third set of tests shall be performed in the same way as the first two and the results shall be assessed in the same manner. If the number of positive results for the third set of tests does not exceed the maximum number of positives per set ("c" value), no further testing for the class of product will be required for the year. If not, see U.2.2.6.

U.2.2.6 Actions required when the number of Salmonella positive test results for the third set of tests exceeds the maximum number of positives per set ("c" value)

If the number of positive test results for Salmonella exceeds the maximum number of positives per set ("c" value), the establishment shall immediately notify the V/IIC. This situation is considered as a very strong indication of a likely failure of HACCP plans for the products sampled and that there may also be serious shortcomings in overall establishment operations. The V/IIC immediately notifies the Operation Veterinarian Specialist-Meat Export or substitute who contacts the Inspection Chief Officer who notifies the Director, Food Import Export Division (FIED).

A full FSEP-HACCP System audit is to take place (as per section 4 of Chapter 18) at the establishment along with a simultaneous in-depth investigation conducted by a team including Operation Veterinarian Specialist-Meat Export or substitute acting on behalf of headquarters. These activities need to take place in an expeditious manner after the number of positive results for the third set of tests exceeds the maximum number of positives per set ("c" value) and may take place before the entire set of samples has been completed.

The in-depth investigation will be aimed at determining the causes of the repeated test results and assessing if the establishment is meeting USDA export requirements as well as Canadian domestic requirements. The investigation team will report its findings to the Director, MPD.

U.2.3 Pre-sampling preparation

Sample collection will be carried out by the individual designated in the establishment's written protocol. Sampling supplies, such as sterile gloves, sterile sampling solutions, hand soap, sanitizing solution, etc., as well as specific materials needed for sampling different carcass types (i.e., specimen sponges in bags and template if sampling cattle or swine carcasses), will need to be assembled prior to beginning sample collection.

When sponges are used, a verification of the sponge's suitability must have been done. Sponges must not possess antimicrobial properties which might reduce bacterial counts. Supplier certification (e.g., letters of guarantee) shall be obtained for each new lot or in-house verification of each new lot of sponges shall be performed.

Such verification typically should consist of immersing a sponge for a number of hours within a seeded bath of transport medium (e.g.: Buffered Peptone Water) to simulate shipping conditions. The bath containing indicator organisms in a known quantity is cultured at the end of the period to verify if the concentration of bacteria has decreased significantly, which would indicate that substances within the sponge are killing bacteria.

For cattle and swine carcass sampling, a template will be needed to mark off the area to sample. The template can be made of metal or aluminum foil, brown paper, flexible plastic, etc. Some disposable templates may come sterilized and individually pre-packaged. To make a reusable template, cut out a piece 10 cm × 10 cm from a sheet larger than the area to be sampled. (Refer to Annex T, Section T.2.12, Illustration 1). If a reusable template is used, it will need to be sanitized with an approved sanitizing solution [e.g., hypochlorite (bleach) solution or alcohol]. However, the template needs to be completely dry before placing it on the carcass. Aluminum foil or paper templates can be used once and discarded. The foil for the template should be stored in a manner to prevent contamination.

Since the area enclosed by the template will be sampled, take care not to touch this area with anything other than the sampling sponge. Using dirty or contaminated material may lead to erroneous results. If an autoclave is available, paper or aluminum foil templates can be wrapped in autoclavable paper and sterilized.

Sterile sampling solutions, Buffered Peptone Water (BPW), can be stored at room temperature. However, at least on the day prior to sample collection, check solutions for cloudiness. Do not use solutions that are cloudy, turbid or contain particulate matter. Place the number of containers of sampling solution (BPW) that will be needed for the next day's sampling in the refrigerator. Ensure that shipping containers, coolant packs and shipping documents are prepared as required.

U.2.4 Random selection of samples

The operator's written procedure must clearly explain how the random selection of samples is achieved. Use of random numbers tables or similar random number generating systems (e.g.: computer-generated, calculator generate, drawing cards, etc.) is required. To ensure that all carcasses (or ground product) have an equal chance of being selected, the procedure must ensure:

  1. the time when sample is to be selected is determined in a random manner (alternatively, random selection of the carcass sequence number achieves this) Footnote 3;
  2. where there is more than one possible site for taking the sample, the site is determined in a random manner. For example:
    • selection of beef and/or hog carcasses when selection is done within coolers (12 or more hours after slaughter) or on transfer chains, grading chains or other rails: the selection of the cooler and site within the cooler where the carcass is to be selected for the sampling period (i.e. day's production) is determined in a random manner; and the selection of the half-carcass or side of carcass to sample is randomly determined;
    • selection of poultry carcass when the selection is done after chilling, at the end of the drip line or last readily accessible point prior to packaging Footnote 4 Footnote 5: that the selection of the chiller/drip line/packaging line where the sample is to be selected for the sampling period (i.e. day's production) is determined in a random manner;
    • selection of raw ground product where there is more than one grinding machine: that the selection of the grinder where the sample is to be selected for the sampling period (i.e. day's production) is determined in a random manner. Raw ground product samples shall be randomly selected and collected after the grinding process and, if possible, before any addition of spices or seasonings, but prior to final packaging.
  3. where the sample selection procedure involves selecting a half-carcass or carcass at a randomly determined sampling time/sampling site, the following procedure is used to eliminate bias and ensure random selection of the beef half-carcass, hog carcass or poultry carcass:

    After having identified the half-carcass or carcass selected by the random procedure from the predetermined point, count back 5 half-carcasses/carcasses and select the next half-carcass/carcass for sampling. Each half-carcass/carcass must have an equal chance of being selected. The reason for counting back five half-carcasses is to avoid any possible bias during selection.

    Additionally, for poultry carcasses only: because only whole (untrimmed) carcasses are to be sampled, if the fifth carcass is not a whole (untrimmed) carcass, count back an additional five carcasses for sample selection. Repeat if necessary.

If more than one shift is operating at the plant, the sample can be taken on any shift, provided the above requirements have been met.

U.2.5 Aseptic techniques/sampling

Extraneous organisms from the environment, hands, clothing, sample containers, sampling devices, etc., may lead to erroneous analytical results. Stringent requirements for microbiological analysis are necessary, therefore, use of aseptic sampling techniques and clean, sanitized equipment and supplies are of utmost importance.

There should be an area designated for preparing sampling supplies, etc. A stainless steel, wheeled cart or table would be useful during sampling. A small tote or caddy could be moved to the location of sampling and could be used for carrying supplies, supporting sample bags when adding sterile solutions to sample bags, etc.

Sterile gloves should be used for collecting samples. The only items which may contact the external surface of the glove are the exposed sample being collected and/or the sterile sample utensil (specimen sponge). Keep in mind that the outside surfaces of the sample container are not sterile. Do not handle the inside surface of the sterile sample containers. Do not touch anything else. The following procedure for putting on sterile gloves can be followed when collecting samples:

  1. Peel open the package of sterile gloves from the top without contaminating (touching, breathing on, contacting, etc.) the exterior of the gloves.
  2. Remove the first glove by holding it from the wrist-side opening inner surface. Avoid any contact with the outer surface of the glove. Insert the washed and sanitized hand into the glove, taking care not to puncture the glove.
  3. Remove the second glove by holding it by the cuff (outer surface). Avoid contaminating the outside of the first glove when pulling on the second glove. Take care not to touch the face, skin, clothes and other non-sterile surfaces.
  4. If at any time you are concerned that a glove may be contaminated, discard it and begin again with Step (a) above.

U.2.5.1 Preparation for sample collection

Prior to collecting samples, review appropriate sampling steps, random selection procedures, and other information that will aid in sample collection.

On the day prior to sample collection, after checking for cloudiness/ turbidity, place the BPW containers that will be needed for the next day's sampling in the refrigerator/cooler. If samples are to be shipped to an off-site facility, pre-chill shipping container and refrigerator packs.

On the day of sampling, gather sample collection bags, sterile gloves, sanitizer, hand soap, sterile solutions for sampling, and specific materials listed under the (i) Materials section of the sample collection section for the type of carcass or ground product to be sampled. Ensure that all sampling supplies are on hand and readily available before beginning sample collection.

Label the sample bags before starting the sampling procedure. Use permanent ink. If you are using paper labels, it is important that the label be applied to the bag at normal room temperature; it will not stick if applied in the cooler.

Outer clothing (frocks, gloves, head gear, etc.) worn in other areas of the plant should be removed before entering the sampling area or preparing to collect samples. Replace outer clothing removed earlier with clean garments (i.e., laboratory coat) that have not been directly exposed to areas of the plant outside of the sampling area.

Sanitize the sample work area surfaces by wiping with a clean disposable paper towel dipped in a freshly prepared 500 parts per million (ppm) sodium hypochlorite solution (0.05% sodium hypochlorite) or other approved sanitizer which provides an equivalent available chlorine concentration. The sample work area surfaces must be free of standing liquid before sample supplies and/or product containers are placed on them.

Before sampling, thoroughly wash and scrub hands to the mid-forearm. Use antibacterial hand soap. If available, this should include a sanitizer at 50 ppm equivalence available chlorine. Dry the hands using disposable paper towels.

U.2.5.2 Specific sample collection procedures:

The following procedures shall be used in the collection of samples for Salmonella testing. They are derived from the same ones that FSIS uses for its sampling activities in the US. To prevent contamination of samples and to ensure national uniformity of results they must be strictly adhered to.

U.2.5.2.1 Sample collection procedures - raw ground product

This method applies to raw ground beef, ground chicken and ground turkey. It will also be the one used for collecting fresh pork sausage samples.

(i) Materials
  1. two sterile self-sealing-type bags, stomacher bags or equivalent
  2. sterile gloves
  3. plastic cable-tie-wrap or thick rubber band for securing bag
(ii) Collection

Ensure that all supplies are on hand and readily available. Use the predetermined random selection procedure to select sample. Samples of raw ground product will be collected after the grinding process, and, if possible, before the addition of any spices or seasonings, but prior to final packaging.

  1. Put on sterile gloves.
  2. Aseptically collect approximately 250 grams of ground product, if possible, before the addition of any spices or seasonings, but just prior to final packaging. (Sample will be about the size of an orange). Use the sterile sampling bag, taking care not to contaminate the inside of the bag with your gloved hand.
  3. Close the bag tightly by twisting the top and securing it with the plastic cable-tie-wrap or rubber band or securely closing the bag seal.
  4. Place bagged sample inside a second bag and close the outer bag tightly.
  5. Follow the procedure in section U.2.6, "Sample shipment".
U.2.5.2.2 Sample collection procedure - cattle half-carcasses
(i) Materials
  1. sterile specimen sponge in sterile bag wire top sealable sample bag or equivalent
  2. 10 mL sterile Buffered Peptone Water (BPW)
  3. sterile self-sealing (Ziploc®-type) bag or stomacher bag
  4. template for 100 cm2 sampling area
  5. sterile gloves
  6. wheeled ladder, sampling platform, or step ladder
  7. sanitizing solution
  8. small tote or caddy for carrying supplies
(ii) Collection

Read section U.2.3 "Pre-sampling preparation" and section U.2.5.1 "Preparation for sample collection" before beginning the sampling procedure. Use pre-determined random selection procedures for selecting the half-carcass to be sampled (randomly selected sequence number or sampling site).

A sampling sponge (which usually comes dehydrated and pre-packaged in a sterile bag) will be used to sample all three sites on the carcass (flank, brisket, and rump - refer to Annex T, Section T.2.12, Illustration 2). It is important to swab the areas in the order of least to most contamination in order to avoid spreading any contamination.

Non-destructive surface sampling will be conducted as follows:

  1. Ensure that all bags have been pre-labelled and all supplies are on hand, including the sampling template. (An assistant may be helpful during the sampling process.)
  2. Position the wheeled ladder, sampling platform, or step ladder near the carcass so the rump sample area (Annex T, Section T.2.12, Illustration 2) is within easy reach from the ladder.
  3. If a reusable template is used, immerse the sampling template in an approved sanitizing solution for at least 1-2 minutes. Just prior to swabbing the first sample site on the carcass (step 13), retrieve the sampling template from the sanitizing solution. Shake all excess solution from the utensil, and then protect the portion of the template that will contact the carcass from contamination.
  4. Locate the flank, brisket, and rump sampling sites using illustrations and directions in Annex T, Section T.2.12 (Illustration 2) (cattle carcass sampling locations).
  5. While holding the sponge bag at the top corner by the wire closure, tear off the clear, perforated strip at the top of the bag.
  6. Remove the cap from sterile BPW bottle, being careful not to touch the bottle opening.
  7. Carefully pour the contents of the sterile BPW bottle (approximately 10 ml) into the sponge bag to moisten the sponge.
  8. Close the top of the bag by pressing the wire closures together. Use hand pressure from the outside of the bag and carefully massage the sponge until it is fully hydrated (moistened).
  9. With the bag still closed, carefully push the moistened sponge to the upper portion of the bag orienting one narrow end of the sponge up toward the opening of the bag. Do not open the bag or touch the sponge with your fingers. While holding the bag, gently squeeze any excess fluid from the sponge using hand pressure from the outside. The whole sponge should still be in the bag.
  10. Open the bag containing the sponge, being careful not to touch the inner surface of the bag with your fingers. The wire closure at the top of the bag should keep the bag open. Set bag aside.
  11. Put on a pair of sterile gloves.
  12. Carefully remove the moistened sponge from the bag with the thumb and fingers (index and middle) of your sampling hand.
  13. With the other hand, retrieve the template by the outer edge, taking care not to contaminate the inner edges of the sampling area of the template.
  14. Locate the flank sampling area (Annex T, Section T.2.12, Illustration 2). Place the template over this location.
  15. Hold the template in place with one gloved hand (Remember; only the sponge should touch the sampling area. Take care not to contaminate this area with your hands.)
  16. With the other hand, wipe the sponge over the enclosed sampling area (10 cm × 10 cm) for a total of approximately 10 times in the vertical and 10 times in the horizontal directions. Avoid touching the template, especially if it has been treated with an anti-microbial agent. The pressure for swabbing would be as if you were removing dried blood from the carcass. However, the pressure should not be too hard as to crumble or destroy the sponge. (Note: The template may need to be "rolled" from side to side during swabbing since the surface of the carcass is not flat. This ensures that the 100 cm2 area is enclosed while swabbing.)
  17. Repeat steps 14-16 for the brisket area, using the same side or surface of the sponge used to swab the flank area.
  18. After swabbing the brisket area, transfer the template to the same hand holding the sponge. Do not contaminate the sponge or inner edges of the sampling area of the template.
  19. Climb the ladder or platform, holding onto the handrail with the hand used to hold the template. Once at a convenient and safe height for sampling the rump, transfer template back to "climbing" hand (hand used to hold onto the rail while climbing the ladder), taking care not to contaminate the inner edges of the template.
  20. Repeat steps 14-16 for the rump area, using the "clean" surface or side (the side that was not previously used to swab the flank/brisket areas) of the sponge.
  21. After swabbing the rump area, carefully place the sponge back in the sponge sample bag, taking care not to touch the sponge to the outside of the sample bag.
  22. While holding the handrail, climb down from the ladder.
  23. Expel excess air from the bag containing the sponge and fold down the top edge of the bag three or four times to close. Secure the bag by folding the attached wire tie back against the bag. Place closed sponge bag into second bag and close the second bag securely.
  24. Follow the procedure in section U.2.6, "Sample shipment".
U.2.5.2.3 Sample collection procedure - swine carcasses
(i) Materials
  1. sterile specimen sponge in sterile sealable wire-top bag or equivalent
  2. 10 ml sterile BPW
  3. sterile self-sealing (Ziploc®-type) bag or stomacher bag
  4. template for 100 cm2 sampling area
  5. sterile gloves
  6. wheeled ladder, sampling platform, or step ladder
  7. sanitizing solution
  8. small tote or caddy for carrying supplies
(ii) Collection

Read section U.2.3 "Pre-sampling preparation" and section U.2.5.1 "Preparation for sample collection" before beginning the sampling procedure. Use pre-determined random selection procedures for selecting the carcass/side of carcass to be sampled (randomly selected sequence number or sampling site).

A sampling sponge (which usually comes dehydrated and pre-packaged in a sterile bag) will be used to sample all three sites on the carcass (ham, belly and jowls - refer to Annex T, Section T.2.12, Illustration 3). It is important to swab the areas in the order of least to most contamination in order to avoid spreading any contamination.

Non-destructive surface sampling will be conducted as follows:

  1. Ensure that all bags have been pre-labelled and all supplies are on hand, including the sampling template. (An assistant may be helpful during the sampling process.)
  2. Position the wheeled ladder, sampling platform, or step ladder near the carcass so the ham sample area (Annex T, Section T.2.12, Illustration 3) is within easy reach from the ladder.
  3. If a reusable template is used, immerse the sampling template in an approved sanitizing solution for at least 1-2 minutes. Just prior to swabbing the first sample site on the carcass (step 13), retrieve the sampling template from the sanitizing solution. Shake all excess solution from the utensil, then protect the portion of the template that will contact the carcass from contamination.
  4. Locate the ham, belly and jowl sampling sites using illustrations and directions in (Annex T, Section T.2.12, Illustration 3)(swine carcass sampling locations).
  5. While holding the sponge bag at the top corner by the wire closure, tear off the clear, perforated strip at the top of the bag.
  6. Remove the cap from sterile BPW bottle, being careful not to touch the bottle opening.
  7. Carefully pour the contents of the sterile BPW bottle (approximately 10 ml) into the sponge bag to moisten the sponge.
  8. Close the top of the bag by pressing the wire closures together. Use hand pressure from the outside of the bag and carefully massage the sponge until it is fully hydrated (moistened).
  9. With the bag still closed, carefully push the moistened sponge to the upper portion of the bag orienting one narrow end of the sponge up toward the opening of the bag. Do not open the bag or touch the sponge with your fingers. While holding the bag, gently squeeze any excess fluid from the sponge using hand pressure from the outside. The whole sponge should still be in the bag.
  10. Open the bag containing the sponge, being careful not to touch the inner surface of the bag with your fingers. The wire closure at the top of the bag should keep the bag open. Set bag aside.
  11. Put on a pair of sterile gloves.
  12. Carefully remove the moistened sponge from the bag with the thumb and fingers (index and middle) of your sampling hand.
  13. With the other hand, retrieve the template by the outer edge, taking care not to contaminate the inner edges of the sampling area of the template.
  14. Locate the belly sampling area (Annex T, Section T.2.12, Illustration 3). Place the template over this location.
  15. Hold the template in place with one gloved hand (Remember; only the sponge should touch the sampling area. Take care not to contaminate this area with your hands).
  16. With the other hand, wipe the sponge over the enclosed sampling area (10 cm × 10 cm) for a total of approximately 10 times in the vertical and 10 times in the horizontal directions. Avoid coming into contact with the template, especially if it has been treated with an anti-microbial agent. The pressure for swabbing would be as if you were removing dried blood from the carcass. However, the pressure should not be too hard as to crumble or destroy the sponge. (Note: The template may need to be "rolled" from side to side during swabbing since the surface of the carcass is not flat. This ensures that the 100 cm2 area is enclosed while swabbing.)
  17. After swabbing the belly area, transfer the template to the same hand holding the sponge. Do not contaminate the sponge or inner edges of the sampling area of the template.
  18. Climb the ladder or platform, holding onto the handrail with the hand used to hold the template. Once at a convenient and safe height for sampling the ham, transfer template back to "climbing" hand (hand used to hold onto the rail while climbing the ladder), taking care not to contaminate the inner edges of the template.
  19. Repeat steps 14-16 for the ham area, using the same surface of the sponge used to swab the belly area.
  20. After swabbing the ham area, carefully place the template back to the same hand that is holding the sponge. Do not contaminate the inner edges of the sampling area of the template.
  21. While holding the handrail with the hand not used for sampling, climb down from the ladder.
  22. Transfer the template back to the "climbing" hand (hand used to hold onto the rail while descending the ladder), taking care not to contaminate the inner edges of the template.
  23. Repeat steps 14-16 for the jowl area, using the "clean" surface or side (the side that was not previously used to swab the belly and ham areas).
  24. After swabbing the jowl area, carefully place the sponge back into the sponge bag. Do not touch the surface of the sponge to the outside of the sponge bag.
  25. Press wire closures on the sponge bag together, expel the excess air, then fold over the top of the bag three or four times. Close the bag with attached wire by bending the wire tie back against the bag to secure it.
  26. Follow the procedure in section U.2.6, "Sample shipment".
U.2.5.2.4 Sample collection procedure - chicken carcasses

Note: Samples will be tested for both Salmonella spp. and Campylobacter (see Annex U-1).

U.2.5.2.4 (a) General procedures
  1. Sample each production shift as identified on the CVS plant profile on a random basis so that the full sampling set includes representative samples from both shifts. Shift sampling proportions may vary and there is no requirement that exactly half of the samples must be taken from each production shift.
  2. The supplies for this new sampling procedure are different from those described in the previous procedure for collecting the sample for Salmonella testing. The following is a list of the supplies for each young chicken sampling event:

    Shipping container:

    1 - 15" × 20" (33 × 44 cm), large sterile plastic bag
    1 - pair of sterile gloves
    1 - 400 mL bottle of Buffered Peptone Water (BPW)
    1 - 120 mL sterile specimen jar with lid
    1 - 1 liter re-sealable Ziploc®-type bag (secondary container)
    1 - Absorbent pad
    Gel coolant packs

    Ensure that the BPW is pre-chilled is critical to this verification sampling procedure. Only use pre-chilled BPW.

  3. Personnel collecting the samples are to change disposable gloves whenever necessary, to prevent cross-contamination of bird samples and are to avoid contamination of carcasses and rinse supplies.
  4. At the post-chill sampling location, establishment personnel are to determine a random time at which the carcasses will reach the end of the drip line, or the last readily accessible point prior to cut-up, (or the equivalent point in air-chill systems). Staff is to randomly select a poultry carcass from the post-chill area (after all interventions have taken place) and to allow drip time to prevent dilution of the sample.
U.2.5.2.4 (b) Specific Procedures for Collecting Young Chicken Rinsate
  1. Personnel are to take all necessary precautions not to contaminate any of the sampling supplies and are to discontinue the sampling procedure if a contamination event occurs that would compromise the integrity of the submitted sample.
  2. Review and follow the instructions for aseptic sampling techniques, putting on the gloves, and sample collection for placing the chicken carcass in the large sterile plastic sample bag, adding pre-chilled BPW, and thoroughly rinsing the bird.
  3. The person conducting the test must remove the chicken aseptically from the sample bag before collecting the 100 mL rinsate.

    To do this:

    1. Carefully open the bag containing the bird;
    2. Work the plastic bag down around the carcass so that you can firmly grip one leg, without touching the inside of the plastic bag;
    3. While holding the bag with the one hand, carefully remove the bird from the bag with the other hand; and
    4. Place the bird back on the conveyor or table.
  4. Collect the 100 mL rinsate sample from the sample bag immediately by:
    1. removing the lid from the empty 120 mL sterile specimen jar container;
    2. being careful not to contaminate the inside of the specimen jar or the lid, and by not allowing the bag to contact the interior surfaces of the jar;
    3. using the "V" formed by the bag at the lower corner as a pouring spout, carefully pour the rinsate into the open jar;
    4. collecting as much of the BPW rinsate as possible, but at least 100 mL;
    5. placing the cap back on the jar and checking to be sure that the lid is securely in place;
    6. placing the collected and labelled sample container in a Ziploc®-type bag; and
    7. holding the sample under refrigeration and control until shipment to the laboratory.
U.2.5.2.5 Sample collection procedure - turkey carcasses

Note: Samples will be tested for both Salmonella spp. and Campylobacter (see Annex U-1).

U.2.5.2.5 (a) General Procedures
  1. Sample each production shift as identified on the CVS plant profile on a random basis so that the full sampling set includes representative samples from both shifts. Shift sampling proportions may vary and there is no requirement that exactly half of the samples must be taken from each production shift.
  2. There will be two carcass swabs per post-chill sample with 10 mL of BPW diluent used to moisten the sponge for the Salmonella sample and 25 mL of BPW diluent used to moisten the sponge for the Campylobacter sample. IPP are to collect one turkey carcass for sampling. The first sponge is to be used to swab the left side of the carcass for Salmonella, while the second sponge is to be used to swab the right side of the carcass for Campylobacter.
  3. The following is a list of the supplies for each young turkey sampling event

    Shipping container
    3 - pairs of sterile gloves
    1 - 10 mL tube of BPW marked "S" (Salmonella)
    1 - 25 mL tube of BPW marked "C" (Campylobacter)
    2 - sterile specimen sponges (swabs) in marked Whirl-Pak® bags; one swab labelled "C", one swab labelled "S"
    2 - sterile templates 5cm × 10cm in bag
    2 - 1 liter re-sealable Ziploc®-type bags (secondary container)
    1 - Absorbent pad
    Gel coolant packs

    Ensure that the BPW is pre-chilled is critical to this verification sampling procedure. Only use pre-chilled BPW.

  4. Personnel are to change disposable gloves whenever necessary, to prevent cross-contamination of birds and samples and are to avoid contamination of carcasses and sponge sampling supplies.
  5. At the post-chill sampling location, personnel are to determine a random time at which the carcass will reach the end of the drip line or the equivalent point in air-chill systems. Personnel are to randomly select a poultry carcass from the post-chill area (after all interventions have taken place) and to allow drip time to prevent dilution of the sample.
U.2.5.2.5 (b) Specific Procedures for Collecting Turkey Swabs

Personnel are to take all necessary precautions not to contaminate any of the sampling supplies and are to discontinue the sampling procedure if a contamination event occurs which would compromise the integrity of the submitted samples.

Staff is to review and follow the instructions for Sample Collection, Turkey, for general turkey sponging technique, but with the following additional instructions:

  1. While wearing the first pair of sterile gloves, remove the turkey in a safe manner. Holding the turkey by the legs and avoiding contact with the back or thigh areas, place the turkey breast down on a sanitized work surface covered with clean paper towels or absorbent pads to prevent the carcass from slipping during sponge sampling. Remove and discard the gloves. If heavy birds require assistance for lifting, have helpers wear sterile gloves and ensure that they do not touch the sampling areas.
  2. Open the sponge bag by tearing off the top perforated strip. Do not remove the wire closures from the bag. Pull apart the two small white tabs on either side to open the mouth of the bag.
  3. Remove the cap from the smaller, 10 mL pre-chilled sterile BPW container marked "S", designated for Salmonella sampling, being careful not to touch the container opening. Carefully pour the entire contents of the BPW container into the sponge bag marked "S". Do not contaminate the top inside of the Whirl-Pak® bag. Set the empty BPW container aside.
  4. Press the wire closures back together to close the top of the sponge bag. Use hand pressure on the outside of the bag to carefully massage the sponge until it is fully moistened. With the bag still closed, squeeze any excess diluent out of the sponge while carefully pushing the moistened sponge to the uppermost portion of the bag.
  5. Open the sponge sample bag, being careful not to touch its inner surface. The wire closure should keep the bag open. Set the bag aside, being careful not to contaminate the sponge and careful not to spill the remaining BPW fluid.
  6. Open the sterile template bag by tearing off the top perforated strip. Set the template bag aside, being careful not to contaminate the template.
  7. Put on the second pair of sterile gloves. Carefully remove the moistened sponge from the bag by grasping the end of the sampling sponge with your gloved sampling hand. Do not touch the outside of the Whirl-Pak® bag.
  8. With your other gloved hand, retrieve the template by its outer edge, taking care not to contaminate the inner edges that define the template's sampling area.
  9. Place the template over the back sampling area and hold it in place to the left of the vertebral column. Using your sampling hand, wipe the sponge over the entire enclosed area approximately 10 times vertically and 10 times horizontally. Use only one side of the sponge. You may need to "roll" the template from side to side as you sponge since the carcass surface is not flat.
  10. Repeat the sponging procedure using the same sponge but with the template placed over the left thigh sampling area. Turn the sponge over so that the unused side of the sponge contacts the thigh surface, wiping the entire area enclosed by the template with approximately 10 vertical and 10 horizontal passes of the sponge. Discard the template.
  11. Carefully replace the sponge into the Whirl-Pak® sample bag with any remaining portion of BPW without touching the outside of the bag with the sponge. Expel any excess air from the sample bag and fold over the top edge of the bag 3 or 4 times to close the top. Secure the top by folding the wire attachments back against the bag.
  12. Repeat steps 4 to 11 using the other, larger, 25 mL pre-chilled sterile BPW container marked "C" designated for Campylobacter sampling and the Whirl-Pak® sponge bag marked "C". Swab the right side of the same turkey carcass using a new pair of gloves and a new template. Upon completion of the second swabbing, and securing the swab in its marked sample bag, return the turkey carcass to the point where you collected the bird.
  13. Each sponge should be carefully secured in its own separate Whirl-Pak® sample bag (previously marked appropriately with either a "S" or a "C").
  14. Place bagged carcass sponges under refrigeration within five (5) minutes of collection. Place the collected and labelled sample bags in their own separate Ziploc® type bag, which is provided, and hold under refrigeration and FSIS control until shipped.

Shipment of samples to the Accredited Laboratory: follow the procedures in section U.2.6.2.

U.2.6 Samples

U.2.6.1 Sample storage prior to shipment

All samples are to be refrigerated after sampling and maintained under refrigeration at 4.0°C, or lower, until shipped. Do not freeze samples. Keep all samples secure.

Staff should never to store sample boxes near heaters or areas exposed to excessive heat. The laboratory will discard samples that arrive above 10°C or below 0°C. It is critical that the sample temperature is maintained during collection and shipment.

U.2.6.2 Sample shipment

Samples must be sent to a laboratory authorized to provide results. See Section U.3. Samples must be collected and shipped for analysis as outlined in section U.2.2.1.

The establishment operator must have procedures detailing how protection from temperature abuse of the sample and possible tampering will be ensured.

A - Protection from temperature abuse

The establishment's written program must describe the procedures used to ensure that the sample temperature arrives at the laboratory as low as possible but without freezing. Laboratories should not be performing analysis on samples which are reaching the laboratory above 10°C. To help ensure that samples arrive at the laboratory at the proper temperature, a procedure similar to the one used by FSIS and described here should be used.

  1. Pre-chill shipping container by placing the open shipping container in the refrigerator at least the day before sampling.
  2. Place the appropriately labelled double-bagged sample in the pre-chilled shipper in an upright position to prevent spillage. Newspaper may be used for cushioning the sample and holding it in the upright position. Ensure that the sample is maintained at refrigeration temperature to prevent multiplication of any microorganisms present and to provide the most accurate results.
  3. Place a corrugated cardboard pad on top of the sample. Next, place the frozen gel pack(s) on top of the corrugated pad to prevent direct contact of frozen gel packs with the sample. Use sufficient frozen coolant to keep the sample refrigerated during shipment to the designated laboratory. Insert a foam plug and press it down to minimize shipper head space.
  4. Ship sample (via overnight delivery or courier) to the accredited laboratory.

B - Protection from tampering

The establishment's written Salmonella sampling program must describe procedures for ensuring tamper-evidence of samples submitted to the independent laboratory. This would include the following: handling and packaging/shipping procedures for samples, personnel involved, location of sample prior to shipment, tamper-proof shipping devices used (e.g., seals), etc.

The V/IIC will review these written procedures before sampling begins to verify that samples cannot be tampered with between the time of sampling and analysis. The V/IIC also monitors these activities on an ongoing basis during testing to verify that written procedures are adhered to and are effective.

U.3 Laboratory accreditation requirements and analytical methods

Laboratories eligible to provide results

To be eligible to provide results, laboratories must be accredited by the SCC or CALA and have on their scope of approved methods, the method(s) of analysis prescribed by the USDA-FSIS. USDA-FSIS methods include a rapid screening procedure (true negative are obtained in 24 hours) and a cultural confirmation method that must be used when potentially positive samples are identified. Laboratories should refer to the FSIS - Microbiology Laboratory Guidebook and to Health Canada's Compendium of Analytical Methods Web sites to ensure that the most current versions are used.

The methods should be referred to in accredited laboratories' scope as:

MLG 4C.03 - FSIS Procedure for the Use of a Polymerase Chain Reaction (PCR) Assay for Screening Salmonella in Raw Meat Products, Raw Catfish Products, Carcass Sponge Samples, Whole Bird Rinses, Ready-to-Eat Meat, Poultry Products, and Pasteurized Egg Products

MLG 4.05 - Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg and Catfish Products

MFLP-29 - The Qualicon Bax® System Method for the Detection of Salmonella in a Variety of Food and Environmental Samples

MFHPB-20 - Isolation and Identification of Salmonella from Foods

Laboratory testing reports must indicate the specific USDA-FSIS method(s) used, or the approved equivalent, as last amended.

A list of accredited laboratories by SCC is available on the SCC Web site

A list of accredited laboratories by CALA is available on the CALA Web site

U.4 Reporting Test Results; Record keeping

A - Accredited Laboratories

Accredited laboratories performing Salmonella testing shall directly report test results in an expeditious and simultaneous manner both to the establishment of origin and directly to the CFIA V/IIC of the establishment. Laboratories shall also maintain records of tests performed as per usual procedures.

B - Registered Establishments

The registered establishment shall have written procedures outlining how laboratory results are received, collated and filed at the establishment. There must be an organized system allowing for ready analysis of the set of tests: a suitably organized log book can suffice for this purpose. Proof of test results (e.g., reports of analysis) shall be kept at the establishment for a period of not less than 24 months. A notification procedure is required for identifying all positive results to the CFIA V/IIC.

C - CFIA V/IIC at the Registered Establishment

The CFIA V/IIC shall keep the laboratory reports sent directly to themselves from the laboratory for a period of at least two years. In addition tracking all positives, the V/IIC will compare their results with the establishment's to verify that the establishment is compiling the correct data in the appropriate manner. Laboratory results are compiled and kept with completed CVS task and sent to Headquarters as soon as each set of samples has been completed.

U.5 Flow Charts for analyzing test results

Click on image for larger view
Flow chart for analysing test results - first set of tests. Description follows.

Description of the Flow chart for analyzing test results - first set of tests

This flow chart lists the steps to follow in the first set of tests for Salmonella.

Notes: No later than December 31st of the current year, the applicable Compliance Verification System task will be completed with the "determination of product to be sampled for Salmonella" worksheet.

Establishments slaughtering more than 20,000 chickens and/or turkeys combined will have to test for Salmonella and Campylobacter at least every two years (refer to Annex U-1 for Campylobacter performance standards).

When more than one class of product is tested during the year, all the required testing for each individual class of product must be done.

If there is a positive result for Salmonella testing, find out if the number of positive test results exceeded the maximum number of positives per set ("c" value)?

If the result is no, that is to say the number of positive results is equal or less than "c", then it is the end of current year testing for Salmonella for this class of product.

However, note that if other classes are included in the year's testing plan, testing for the other class(es) continues independently. The same applies in the case of young chicken or turkey carcasses that failed Campylobacter standards and have to be retested for both microorganisms.

If the result is yes:

  • the establishment must:
    • immediately notify the Veterinarian/Inspector in Charge
    • investigate possible causes and provide action plan to the Canadian Food Inspection Agency Veterinarian/Inspector in Charge within 5 working days
  • the Veterinarian/Inspector in Charge:
    • forwards action plan to the Operation Veterinarian Specialist-Meat Export or substitute with comments
  • If there are additional positive test results for Salmonella, the establishment must:
    • immediately notify the Veterinarian/Inspector in Charge
    • review the action plan and implement corrective actions

Conclusion of the first set of tests if the total number of valid test results equals the "n" value.

If the number of positive test results is greater than "c" a second set of tests is required. In this case:

  • the establishment must:
    • provide copies of all action plans plus a summary of test results to the Veterinarian/Inspector in Charge (within 5 working days of end of set of tests).
  • the Veterinarian/Inspector in Charge:
    • attaches comments and forwards them to the Operation Veterinarian Specialist-Meat Export or substitute.
  • the Operation Veterinarian Specialist-Meat Export or substitute:
    • reviews the file and instructs the Veterinarian/Inspector in Charge on when a second set of tests should begin (immediately or after execution of company's action plan)

Note that chicken and turkey carcasses shall be retested for both Salmonella and Campylobacter.

Click on image for larger view
Flow chart for analysing test results - second set of tests. Description follows.

Description of flow chart for analyzing test results - second set of tests

This flow chart lists the steps to follow in the second set of tests for Salmonella

If there is a positive result for Salmonella testing, find out if the number of positive test results exceeded the maximum number of positives per set ("c" value)?

If the result is no, that is to say the number of positive results is equal or less than "c", then it is the end of current year testing for Salmonella for this class of product.

However, note that if other classes are included in the year's testing plan, testing for the other class(es) continues independently.

Note that chicken and turkey carcasses will be tested for both Salmonella and Campylobacter.

If the result is yes:

  • the establishment must:
    • immediately notify the Veterinarian/Inspector in Charge
    • investigate possible causes and provide action plan to the Canadian Food Inspection Agency Veterinarian/Inspector in Charge within 5 working days

    This includes:

    • systematic review of all Hazard Analysis Critical Control Point plans for the product(s) within the category sampled for Salmonella
    • initiation of corrective actions indicated as a result of this review
  • the Veterinarian/Inspector in Charge:
    • forwards action plan to the Operation Veterinarian Specialist-Meat Export or substitute with comments

If there are additional positive test results for Salmonella:

  • the establishment must:
    • immediately notify the Veterinarian/Inspector in Charge
    • review the action plan and implement corrective actions

Conclusion of the second set of tests if the total number of valid test results equals the "n" value

If the number of positive test results is greater than "c" a third set of tests is required. In this case:

  • the establishment must:
    • provide copies of all action plans plus a summary of test results to the Veterinarian/Inspector in Charge (within 5 working days of end of set of tests).
  • the Veterinarian/Inspector in Charge:
    • attaches comments and forward them to the Operation Veterinarian Specialist-Meat Export or substitute
  • the Operation Veterinarian Specialist-Meat Export or substitute:
    • reviews the file and instructs the Veterinarian/Inspector in Charge on when a second set of tests should begin (immediately or after execution of company's action plan)

Note: Because changes are normally required to the establishment's Hazard Analysis Critical Control Point system when Performance Standards for Salmonella are twice exceeded, unless the Operation Veterinarian Specialist-Meat Export or substitute assesses that the situation demands immediate retesting, the establishment is provided with time to make the changes and to undergo a Food Safety Enhancement Program-Hazard Analysis Critical Control Point audit of the modifications to the Hazard Analysis Critical Control Point system as per Chapter 18.

Click on image for larger view
Flow chart for analysing test results - third set of tests. Description follows.

Description of flow chart for analyzing test results - third set of tests

This flow chart lists the steps to follow in the third set of tests for Salmonella.

If there is a positive result for Salmonella testing, find out if the number of positive test results exceeded the maximum number of positives per set ("c" value)?

If the result is no, that is to say the number of positive results is equal or less than "c", then it is the end of current year testing for Salmonella for this class of product.

However, note that if other classes are included in the year's testing plan, testing for the other class(es) continues independently. The same applies in the case of young chicken or turkey carcasses that failed Campylobacter standards and have to be retested for both microorganisms.

If the result is yes:

  • the establishment must:
    • immediately notify the Veterinarian/Inspector in Charge
  • the Veterinarian/Inspector in Charge:
    • immediately notifies the Operation Veterinarian Specialist-Meat Export or substitute
  • The Operation Veterinarian Specialist-Meat Export or substitute:
    • contacts the Inspection Chief Officer
  • the Inspection Chief Officer:
    • immediately notifies the Director, FIED
    • ensures that the necessary arrangements are made for a full Food Safety Enhancement Program Hazard Analysis Critical Control Point system audit at the establishment and an in-depth review which must be conducted with Headquarters participation

U.6 Worksheet: Determination of product to be sampled for Salmonella - page 1

Instructions to the IIC/VIC: Use this form when completing the applicable CVS task. Have the establishment provide you with a listing of products made at the establishments which are amenable to a Salmonella Performance Standard. The products need to be grouped by Performance Standard class and ranked in descending volume of production (i.e., class most produced to class least produced). All establishments slaughtering more than 20,000 chickens and/or turkeys combined will have to test the carcasses every two years at a minimum. The samples will be tested for both Salmonella and Campylobacter (see Annex U-1 for Campylobacter performance standards).

Complete one copy of this form for each class of product manufactured at the establishment which is amenable to a Salmonella Performance Standard. Staple a copy of the completed forms to form 4A and keep in the IIC/VIC's office.

PDF (23 kb)

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Worksheet: Determination of product to be sampled for Salmonella - page 1. Description follows.

Description for Worksheet: Determination of product to be sampled for Salmonella - page 1

Is the class of product exempt from testing? (Refer to section U.1.1). If Yes, proceed no further. If no, proceed to questions.

Question 1
Was this class tested in the previous year?

If Yes, award zero points
If No, award four points. Note that, if these are carcasses of either young chickens or turkeys that were not tested the previous year, they shall be tested this calendar year.

If yes, what were the results?
If passed first round of testing successfully, award = 0 points
If failed first round but passed second round successfully, award = 1 point
If failed first two rounds but passed third round successfully, award = 3 points
If failed first, second and third round but successfully returned to compliance, award = 5 points

Question 2
Has the establishment modified its manufacturing practices for the class of product?
If Yes, award = 2 points
If No, award = 0 points

Question 3
What were the results of generic E. coli (biotype I) testing for the previous year?
If they consistently met or occasionally exceeded the Performance Verification Criteria (PVC), award = 0 points
If they regularly exceeded the PVC (twice or more per month on average), award = 2 points

Question 4
Have written instructions been received from the CFIA Program Network Center which indicate that testing for this class is to be performed during the upcoming year?
If Yes, award = 5 points
If No, award = 0 points

Testing for Salmonella shall be done on the class of product with the highest point score and also on any class of products which have a total point score of 5 or more.

In case of a tie, testing for Salmonella will be done on the product that has the largest production volume by weight.

U.6 Worksheet: Determination of product to be sampled for Salmonella - page 2

PDF (16 kb)

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Worksheet: Determination of product to be sampled for Salmonella - page 2. Description follows.

Description of Worksheet: Determination of product to be sampled for Salmonella - page 2

Page 2 of the Determination of product to be sampled for Salmonella - Worksheet contains the following information:

Establishment Number:

Class of Product

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Ranking - by volume of production for example 1, 2, 3

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Is the Product Exempt from Testing? (Yes/No)

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Points Awarded - Question number 1

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Points Awarded - Question number 2

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Points Awarded - Question number 3

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Points Awarded - Question number 4

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Points Awarded - Total Points

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Testing Required (Yes/No)

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Date of the beginning of testing:(month/day)

  • Steer/heifer
  • Cow/bull carcasses
  • Ground beef
  • Swine carcasses
  • Young chicken carcasses
  • Ground chicken
  • Young turkey carcasses
  • Ground turkey

Date:

Canadian Food Inspection Agency Veterinarian-in-Charge / Inspector-in-Charge (Signature):

Note1 for ground poultry meat: Only poultry carcasses shall be tested for both Campylobacter and Salmonella. For the purpose of annual testing to verify Salmonella performance standards, ground poultry meat must be considered as a separate class of product altogether.

Date modified: